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Vaccine Therapy for Patients With Stage IIIC-IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer

Recurrent Ovarian Carcinoma Clinical Trial

Official title:
A Pilot Study of the Safety and Immunogenicity of Folate Receptor Alpha Peptide-Loaded Dendritic Cell Vaccination in Patients With Advanced Stage Epithelial Ovarian Cancer

Clinical Trial Summary

This pilot clinical trial studies the safety and immunogenicity of vaccine therapy in treating patients with stage IIIC-IV ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer following surgery and chemotherapy. Vaccines made from a person's peptide treated white blood cells may help the body build an effective immune response to kill tumor cells.

Clinical Trial Description

PRIMARY OBJECTIVES: I. Determine the safety and tolerability of folate receptor alpha dendritic cell (FRalphaDC) vaccination (folate receptor alpha-peptide loaded dendritic cell vaccine). SECONDARY OBJECTIVES: I. Measure time to disease recurrence of patients treated with FRalphaDCs. II. Measure overall survival of patients treated with FRalphaDCs. TERTIARY OBJECTIVES: I. Determine whether FRalphaDC vaccination induces an increase in the number of FRalpha-specific interleukin (IL)-17-secreting T helper (Th) cells, as determined by enzyme-linked immunosorbent spot (ELISpot). II. Determine whether FRalphaDC vaccination induces an increase in the number of FRalpha-specific T cells that secrete interferon (IFN)gamma, tumor necrosis factor (TNF)alpha, IL-10, and granzyme B, as determined by ELISpot. III. Determine whether FRalphaDC vaccination induces antibodies specific for FRalpha. IV. Determine whether FRalphaDC vaccination induces a delayed type hypersensitivity (DTH) skin reaction specific for FRalpha. V. Measure FRalpha expression in patients' primary tumors and in tumors that recur after FRalphaDC vaccine treatment (when available). VI. Determine whether FRalphaDC vaccination is associated with changes in peripheral blood immune cell subsets. OUTLINE: This is a dose-escalation study. INDUCTION PHASE: Patients receive folate receptor alpha peptide-loaded dendritic cell vaccine intradermally (ID) on day 1. Treatment repeats every 3 weeks for 5 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive folate receptor alpha peptide-loaded dendritic cell vaccine ID on day 1. Treatment repeats every 3 months for 7 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3-6 months for up to 5 years. ;

Study Design

Related Conditions & MeSH terms

  • Adenocarcinoma
  • Carcinoma
  • Carcinoma, Endometrioid
  • Carcinoma, Ovarian Epithelial
  • Carcinoma, Transitional Cell
  • Cystadenocarcinoma
  • Fallopian Tube Clear Cell Adenocarcinoma
  • Fallopian Tube Endometrioid Tumor
  • Fallopian Tube Mucinous Neoplasm
  • Fallopian Tube Neoplasms
  • Fallopian Tube Serous Neoplasm
  • Fallopian Tube Transitional Cell Carcinoma
  • Neoplasms
  • Neoplasms, Cystic, Mucinous, and Serous
  • Ovarian Clear Cell Cystadenocarcinoma
  • Ovarian Endometrioid Adenocarcinoma
  • Ovarian Mucinous Cystadenocarcinoma
  • Ovarian Neoplasms
  • Ovarian Seromucinous Carcinoma
  • Ovarian Serous Cystadenocarcinoma
  • Ovarian Transitional Cell Carcinoma
  • Peritoneal Neoplasms
  • Primary Peritoneal Serous Adenocarcinoma
  • Recurrence
  • Recurrent Fallopian Tube Carcinoma
  • Recurrent Ovarian Carcinoma
  • Recurrent Primary Peritoneal Carcinoma
  • Stage IIIC Fallopian Tube Cancer
  • Stage IIIC Ovarian Cancer
  • Stage IIIC Primary Peritoneal Cancer
  • Stage IV Fallopian Tube Cancer
  • Stage IV Ovarian Cancer
  • Stage IV Primary Peritoneal Cancer
  • Undifferentiated Fallopian Tube Carcinoma
  • Undifferentiated Ovarian Carcinoma
Clinical Trial Details
NCT number NCT02111941
Study type Interventional
Source Mayo Clinic
Contact
Status Active, not recruiting
Phase Early Phase 1
Start date April 14, 2014
Completion date June 2024
View Details
See also
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